Understand and Leverage the Role of FMEAs in Advanced Quality Planning

Failure Mode and Effects Analysis (FMEA), including design (DFMEA) and process (PFMEA), is an important part of advanced quality planning (AQP) or Advanced Product Quality Planning (APQP). Its purpose is to identify potential failure modes (how the product or process could cause poor quality or, even worse, safety problems) along with their severity, likelihood of occurrence, and likelihood of detection and therefore interception. Deliverables consists of identifying critical to quality characteristics and action plans for eliminating or mitigating risks related to them. Some FMEA concepts (assessment of severity and probability) carry over to ISO 9001:2015's requirement for risk-based thinking.

Learn the role of FMEAs in advanced quality planning (AQP) and more by attending this session by expert speaker William A. Levinson.

Session Highlights:

Understand FMEA as a cross-functional activity which aims to plan, rather than inspect or even build, quality into a product or service.

Recognize critical characteristics (those that can impact safety or regulatory compliance) and significant characteristics (those that can impact conformance to customer requirements).

Know the numerical rating systems for severity (S), likelihood of occurrence (O), and likelihood of detection (D), and how to multiply them to get a risk priority number (RPN).

Recognize that the FMEAs are living documents that drive continuous improvement through action plans for any deficiencies.

Learn how to apply the FMEA concepts of severity and likelihood of occurrence to risk-based thinking for ISO 9001:2015.

Key Takeaways:

Learn not only what FMEAs are as isolated activities, but also how they fit into an overall quality system.

Understand how FMEAs support provisions 7.3 and 7.5 of ISO 9001:2008, and also their mandatory role in the automotive sector.

Recognize that the risk priority number (RPN) is not the only factor in prioritization of improvement activities. Critical product or service characteristics, those that affect safety and/or regulatory compliance, always require attention.

Know the quality system considerations (documentation and quality records) that are associated with FMEAs.

Identify the relationship between FMEA and the Army's Risk Management Process, which supports the ISO 9001:2015 risk-based thinking requirement.

Who Should Attend

Quality management professionals

Engineers and technicians with quality management system responsibilities

Design engineers

People with responsibilities for ISO 9001:2015 or ISO/TS 16949 compliant systems

VP Engineering

Office Managers & Admin

About Our Speaker(s)

William A. Levinson P.E.William A. Levinson, P.E., is the principal of Levinson Productivity Systems, P.C. He is an ASQ Fellow, Certified Quality Engineer, Quality Auditor, Quality Manager, Reliability Engineer, and Six Sigma Black Belt. He is also the author of several books on quality, productivity, and management, of which the most recent ... More info